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USFDA Guidance: Waiver Requests for pH Adjusters in Generic Parenteral, Ophthalmic, or Otic Drugs
The U.S. Food and Drug Administration (FDA) has released a final Guidance for Industry yesterday (17 November, 2025) titled “ Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use ” that is intended to assist abbreviated new drug application (ANDA) applicants that reference a drug product intended for parenteral, ophthalmic, or otic use in seeking approval of a drug that is qualitatively (Q1) different
Sharan Murugan
Nov 17, 20253 min read
Swiss Medic Guidance: Product Information & Packaging for Human Medicinal Products
Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...
Sharan Murugan
Mar 4, 20231 min read
Guidance for Residual Solvents: Q3C(R8) Impurities
This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical...
Sharan Murugan
Dec 18, 20212 min read